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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M/L TAPER STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN M/L TAPER STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Erosion (1750); Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Event Date 09/23/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). No product was returned or pictures provided; visual and dimensional evaluations could not be performed. Part and lot identification are necessary for review of device history records, neither were provided. Radiographs were provided and reviewed by a health care professional. Review of the available records identified the following: right total hip arthroplasty with screw fixation of the acetabular cup, no wear. No radiolucency. No fracture. Heterotopic ossification formation is present. A definitive root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03231, 0001822565 - 2021 - 02823.
 
Event Description
It was reported by patient¿s legal counsel reported patient underwent a right hip arthroplasty. Legal counsel further reports patient underwent a revision procedure sixteen (16) years post implantation due to unknown reasons, heterotopic ossification was identified. The femoral head was replaced. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN M/L TAPER STEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12781093
MDR Text Key280569539
Report Number0001822565-2021-03232
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/02/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/09/2021 Patient Sequence Number: 1
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